Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis (MUCOSIM)
Primary Purpose
Cystic Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SIMEOX
Autogenic drainage
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Physiotherapy, Drainage
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cystic fibrosis confirmed
- Age ≥18 years
- 30% <FEV1 <70% predicted
- Presence of bronchial congestion reported by the patient or the investigator
Exclusion Criteria:
- Uncontrolled asthma
- Pneumothorax <6 weeks
- Recent severe hemoptysis <6 weeks
- Patient registered on the transplant list
- Exacerbation within 4 weeks (3 months if hospitalization) before screening
- Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions
- Patients unable to perform measurements of ROF, spirometry, plethysmography.
- Any contraindication to manual or instrumental physiotherapy.
- Pregnancy, breastfeeding.
- Patient under tutorship or curatorship
- No affiliation to the French social security
- Patient using Simeox at home
- Patient under Trikafta for less than 6 weeks.
- Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion
Sites / Locations
- CH AmiensRecruiting
- Hôpital la Bocage CHRU de DijonRecruiting
- CHRU Lille - Hopital CalmetteRecruiting
- GH Sud - Hospices Civils de Lyon
- CH NiceRecruiting
- Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYSRecruiting
- CHU de RouenRecruiting
- Hopital LarreyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SIMEOX
Autogenic Drainage
Arm Description
Outcomes
Primary Outcome Measures
Low frequency resistance R5
Comparison of variations V4 and V8 sessions (pre and post airway clearance session)
Secondary Outcome Measures
Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue
Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations
Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)
Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)
Full Information
NCT ID
NCT04010253
First Posted
July 3, 2019
Last Updated
July 20, 2022
Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT04010253
Brief Title
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
Acronym
MUCOSIM
Official Title
Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Physiotherapy, Drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SIMEOX
Arm Type
Experimental
Arm Title
Autogenic Drainage
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
SIMEOX
Intervention Description
Instrumental airway clearance by the medical device SIMEOX
Intervention Type
Other
Intervention Name(s)
Autogenic drainage
Intervention Description
Manual aiway clearance by autogenic drainage
Primary Outcome Measure Information:
Title
Low frequency resistance R5
Description
Comparison of variations V4 and V8 sessions (pre and post airway clearance session)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue
Time Frame
1 month
Title
Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations
Time Frame
1 month
Title
Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)
Time Frame
1 month
Title
Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cystic fibrosis confirmed
Age ≥18 years
30% <FEV1 <70% predicted
Presence of bronchial congestion reported by the patient or the investigator
Exclusion Criteria:
Uncontrolled asthma
Pneumothorax <6 weeks
Recent severe hemoptysis <6 weeks
Patient registered on the transplant list
Exacerbation within 4 weeks (3 months if hospitalization) before screening
Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions
Patients unable to perform measurements of ROF, spirometry, plethysmography.
Any contraindication to manual or instrumental physiotherapy.
Pregnancy, breastfeeding.
Patient under tutorship or curatorship
No affiliation to the French social security
Patient using Simeox at home
Patient under Trikafta for less than 6 weeks.
Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline DELRIEU, PhD
Phone
0156814060
Email
delrieu@antadir.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry PEREZ, MD
Organizational Affiliation
CHRU Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Amiens
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire POULET, MD
Facility Name
Hôpital la Bocage CHRU de Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume BELTRAMO, MD
Facility Name
CHRU Lille - Hopital Calmette
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry PEREZ, MD
Email
thierry.perez@chru-lille.fr
Facility Name
GH Sud - Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Suspended
Facility Name
CH Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie LEROY, MD
Facility Name
Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS
City
Roscoff
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas ROPARS, MD
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane DOMINIQUE, MD
Facility Name
Hopital Larrey
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlène MURRIS-ESPIN, MD
12. IPD Sharing Statement
Learn more about this trial
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
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